Officials See No Public Health Threat in Shortage of a Meningitis Vaccine

By DONALD G. McNEIL Jr.

Published: December 13, 2007

A developing shortage of vaccine against childhood meningitis is expected to inconvenience some pediatricians and parents, but should not become a public health threat, officials from the Centers for Disease Control and Prevention and the Food and Drug Administration said Wednesday.

Merck recalled about one million doses of its Hib vaccine this week, and will probably not make more for about a year, a company official said.

The vaccine protects against Haemophilus influenzae Type B, known as Hib, a type of bacteria found in the nose and throat. Most children are not harmed by it, but on rare occasions it can invade the lining of the brain, the bloodstream or the lungs, causing meningitis, sepsis or pneumonia, possibly leading to brain damage or death.

Before the vaccine was adopted in the early 1990s, about 20,000 healthy American children a year were seriously harmed and about 1,000 died from Hib, the disease control centers said. Now fewer than 100 a year develop any detectable Hib disease.

Merck produces five million to seven million doses of the vaccine each year, about half the national supply. Factory testing found that the 45-liter bottles in which the vaccine was brewed had not been fully sterilized during production, so manufacturing was stopped, said Michael F. Thomas, general manager of Merck's vaccine division. But no contamination was found in any of the recalled batches, federal officials said.

''This is not a health-threatening situation for children,'' said Dr. Julie L. Gerberding, director of the disease control centers.

Dr. Gerberding said the vaccine from the recalled batches was fully potent. Any child who received it would be ''protected against haemophilus, so there is no need to re-immunize,'' she said.

It will take up to a year to recertify the factory line of the vaccine. Federal officials have asked a Merck rival, Sanofi Pasteur, which makes about the same amount as Merck, to increase production. And the C.D.C. has about 750,000 doses in its national stockpile.

Children normally receive two doses of the Merck vaccine. If scarcities develop, most children can be given one dose, conserving enough for immunocompromised children and American Indian and Eskimo children, who are at much greater risk.

An outbreak of Hib disease is unlikely because 92 percent of children are immunized, so the bacteria are not circulating widely, Dr. Gerberding said. Other countries with high vaccination rates have had vaccine supplies cut off for up to a year without outbreaks, she added.